Vascular suturing device

ABSTRACT

A surgical device of suturing vascular vessels is described, as well as methods for suturing tissue employing the surgical device. In one form the device includes a distal member that contains a suture and needle engaging fitting. A needle is advanced through tissue adjacent the puncture wound and into the needle engaging fitting to draw lengths of suture material which can then be used to close the puncture wound. In another form the device includes a needle advanceable through tissue and into a needle capture element within a distal end of the surgical device to draw lengths of suture material which can then be used to close various puncture wounds. In still another form the device includes at least one needle advanceable to draw lengths of suture material to close various puncture wounds. A foot is pivotal between a non-deployed and a deployed position.

CROSS-REFERENCE TO RELATED APPLICATIONS

This is a divisional application of U.S. patent application Ser. No.11/997,379 entitled “Vascular Suturing Device”, filed Sep. 10, 2008,which claims the benefit of and priority to PCT Application NumberPCT/US2006/028358 entitled “Vascular Suturing Device”, filed Jul. 21,2006, which is a continuation-in-part of U.S. patent application Ser.No. 11/199,338, entitled “Vascular Suturing Device”, filed Aug. 8, 2005,U.S. patent application Ser. No. 11/199,496, entitled “Vascular SuturingDevice with Needle Capture”, filed Aug. 8, 2005, and U.S. patentapplication Ser. No. 11/199,515, entitled “Vascular Suturing Device”,filed Aug. 8, 2005, each of which is incorporated herein by reference inits entirety.

BACKGROUND OF THE INVENTION

The present invention generally relates to surgical instruments andmethods of suturing tissue.

A number of diagnostic and treatment procedures are conductedintravascularly. Typically, a catheter is introduced into the vascularsystem at a convenient access location and is then guided to the targettreatment site. The Seldinger Technique is one of the well-known earlyexamples of this type of procedure which can include catheterization andangioplasty techniques. Procedures such as this require a vascularaccess. Typically an introducer sheath with or without a guide wire isinserted through a puncture wound in a vessel such as the femoral arteryat a location near the groin. A catheter and other instrumentation canthen be inserted through the sheath and guided to the targeted treatmentsite. After the diagnostic and/or treatment procedure has beencompleted, the puncture wound must be closed. Closing the wound can bedifficult because of the substantial bleeding that can occur through anopen wound in the vascular vessel. One technique for hemostasis includesapplying pressure near or upstream of the puncture site. This approachsuffers from many deleterious effects, not the least of which are thatit can be time consuming and extremely uncomfortable—even painful—forthe patient because the pressure is applied directly on or adjacent tothe traumatized site. Frequently anticoagulants are employed for theoriginal diagnostic/treatment procedures. This delays clot formationduring the procedure, and this effect lasts through the initial recoveryperiod, lengthening the time during which pressure must be applied tothe wound for up to twelve hours or more. During this initial recoveryperiod, it is imperative that the patient remain still, further addingto the patient's discomfort.

Alternatively, the puncture wound can be closed with sutures. This canbe extremely difficult because the vascular vessel with the puncturelies underneath the patient's outer skin. Some vascular vessels, notablythe femoral artery, appear to be relatively large; however, in practice,even the largest arteries cannot be readily sutured. Therefore, deviceshave been developed to facilitate subcutaneous suturing of arteries andveins. These devices can extend through the outer tissue to the puncturewound in the vascular vessel. Needles are then deployed from the deviceto suture the tissue adjacent the puncture wound.

Certain devices are inserted through the wound and initially deployneedles to pierce the tissue in from outside the vascular vessel andcontinue on into a depository in the portion of the device locatedwithin the lumen of the vessel. The suturing device can be removed fromthe vessel (and the patient) by withdrawing the needles and suturematerial at the same time. These devices leave an inverted suture pathafter completion of the closure. The suture material runs from theexterior tissue surrounding the puncture wound back up through the wounditself which is then tied off. Some complications may arise resultingfrom this type of closure, including oozing, excessive bleeding, and, onrare occasions, knot loosening. It would be preferred to provide asuturing device that allows the suture path to extend across thepuncture opening internal of the vessel membrane with the suture knotoverlying the exterior of the closed wound.

Furthermore, while the above-described techniques are regularlyperformed, as with any surgical procedure, they involve considerablerisk to patients. These particular procedures entail delicate andintricate procedures. The physical condition of the patient and,importantly, the condition of the patient's vascular system can greatlyimpact the risks and prognosis. For example, a patient's vascularvessels may be more or less compliant. This can cause furthercomplications making suturing of the puncture wound more difficult. Manycurrent suturing devices cannot accommodate and support non-compliantvascular tissue because the sutures can be misplaced, not attachsufficient tissue, or pull out making wound closure more risky for thesepatients. Devices which can Support tissue and facilitate correct sutureplacement would reduce some of the risks attendant with this procedure.

In view of the above background, there remain needs for improved and/oralternative methods and devices for closing vascular opening orpunctures. The present invention is addressed to these needs.

BRIEF SUMMARY OF THE INVENTION

The present invention relates to suturing device and the use thereof.Various aspects of the invention are novel, nonobvious, and providevarious advantages. While the actual nature of the invention coveredherein can only be determined with reference to the claims appendedhereto, certain forms and features, which are characteristic of thepreferred embodiments disclosed herein, are described briefly asfollows.

In one form, the present invention provides a suturing device forsuturing an opening in a vascular vessel. The device comprises aproximal member that can be configured as an elongate body with a needlechannel extending at least partway therethrough and sized to receive atleast one needle; a distal member configured to be inserted within alumen of a vascular vessel, where the distal member has a receptaclelocated therein and a length of suture material with a needle engagingfitting positioned in the receptacle; and an intermediate memberdisposed between the proximal member and the distal member. In oneembodiment, the intermediate member defines a tissue receiving area andhas a first opening providing a passageway to the channel and a secondopening providing a passageway into the receptacle. In otherembodiments, the distal member defines a substantially linearlongitudinal axis and the intermediate member can deviate from thatlongitudinal axis. In other embodiments, the intermediate defines atissue receiving area that provides a linear needle pathway through thetissue receiving area.

In another form, the present invention provides a suturing device forsuturing an opening in a vascular vessel. The suturing device comprises:a proximal member including an elongate body having a needle channeltherethrough sized to receive at least one needle and including a needlecartridge slidably mounted thereon configured to contain two or moreneedles; a distal member configured to be inserted within a lumen of avascular vessel and having a receptacle located therein and a length ofsuture material with a needle engaging fitting positioned in thereceptacle; an intermediate member disposed between the proximal memberand the distal member, where the intermediate member defines a tissuereceiving area and has a first opening providing a passageway to thechannel and a second opening providing a passageway into the receptacle,and a length of suture material comprising a needle engaging fittingpositioned in the receptacle to engage a needle entering from the secondopening.

In yet another form, the present invention provides A method of suturingan opening in a vascular vessel, said method comprising: inserting avascular suturing device through the opening in the vascular vessel,said suturing device comprising a proximal member having a needlechannel and a needle therein; a distal member configured to be insertedinto the lumen of the vascular vessel, the distal member having a cavitytherein and a length of suture material disposed in the cavity; and aconnecting member between the proximal and distal members, theconnecting member angled or curved to offset the channel and the cavityfrom the opening in the vascular vessel and having a first opening intothe needle channel and a second opening into the cavity; sufficientlyadvancing the needle through the needle channel to pierce a portion oftissue adjacent the opening in the vessel and extend into the cavity ofthe distal member; and capturing the suture within the cavity with theneedle; and retracting the needle carrying a first portion of the sutureback through the tissue and the channel.

In another form, the present invention provides a suturing device forsuturing. The suturing device provides particular advantages, forsuturing a wall portion of a vascular vessel. The device comprises: aproximal member including an elongate body with a channel sized toreceive a needle therein; a distal member comprising a receptacletherein, where the distal member is configured to be inserted into avascular vessel, and wherein the receptacle is sized to receive at leastone needle therein; an intermediate member disposed between the proximalmember and distal member, where the intermediate member defines a tissuereceiving area and provides a first passageway from the channel to thetissue receiving area and second passageway from the receptacle in thedistal member to the tissue receiving area. In preferred embodiments aneedle capture element positioned in the receptacle of the distalmember. The needle capture element is configured to secure a needleinserted into the receptacle.

In another form, the present invention provides a method of suturingvascular tissue adjacent an opening in a vascular vessel. The methoduses a suturing device which can be inserted through the opening in thevascular vessel. The device comprises: a proximal member with a needlechannel formed therein; a distal member configured to be inserted intothe lumen of the vascular vessel, where the distal member has areceptacle that includes a needle capture element and which is sized toreceive at least one needle; and an intermediate member disposed betweenthe proximal member and the distal member. The intermediate memberdefines a tissue receiving area and is configured to provide a linearneedle pathway between the channel and the receptacle. A needle isadvanced through or along the needle channel to pierce the vasculartissue drawing a portion of the length of suture material through thevascular tissue. The needle is further advanced so that a portion of theneedle engages with the needle capture element in the receptacle.Preferable the needle capture element prevents and in advertingdislodging of the needle from the receptacle during the surgicalprocedure. However, the same needle capture element also allows thesurgeon to remove the needle when and if desired.

In another form the present invention provides a suturing device forsuturing an opening in a vascular vessel. The device comprises: aproximal member including an elongate body with a needle channeltherethrough sized to receive at least one needle; a distal memberconfigured to be inserted within a lumen of a vascular vessel, where thedistal member has a receptacle to receive one or more of the needlesafter located they have passed through the tissue; an intermediatemember disposed between the proximal member and the distal member anddefining a tissue receiving area with a first opening providing apassageway to the channel and a second opening providing a passagewayinto the receptacle; and a foot pivotally mounted on the intermediatemember to engage with a portion of the tissue.

In another form the present invention provides a method of suturing anopening in a vascular vessel. The method comprises: inserting a suturingdevice through the opening in the vascular vessel wherein the suturingdevice comprises a proximal member having a needle channel therein; adistal member configured to be inserted into the lumen of the vascularvessel with a receptacle therein sized to receive at least one needle;an intermediate member disposed between the proximal and distal memberand having a first opening providing a passageway way to the needlechannel and a second opening providing a second passageway into thereceptacle and wherein the intermediate member is angled or curved tooffset the needle channel and the receptacle from the opening in thevascular vessel; and a foot pivotally mounted on the intermediatemember. The method also comprises: deploying the foot to contactvascular tissue adjacent the opening; and advancing a first needlethrough the needle channel to pierce a portion of vascular tissue at afirst suture site adjacent the opening in the vascular vessel and intothe receptacle in the distal member. Additionally the device can berelocated within the vessel to advance a second needle and length ofsuture material through the tissue. The ends of the two lengths ofsuture material can be pulled taut to close the wound or opening thevessel. A surgical knot or other knot replacement technology can beutilized to complete the wound closure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded view of one embodiment of a suturing device inaccordance with the present invention.

FIG. 1A is an illustration of suture material suitable for use in thesuturing device of FIG. 1 accordance with the present invention.

FIG. 2 is a cross-sectional view of the suturing device of FIG. 1including the suture material of FIG. 1A.

FIG. 3 is a perspective view of a ferrule and a needle for use with thesuturing device in accordance with the present invention.

FIG. 4 is a cross-sectional view of the ferrule engaged with the needleof FIG. 3.

FIG. 5 is an enlarged, cross-sectional view of the intermediate memberof the suturing device of FIG. 1 with the suture material of FIG. 1A.

FIG. 6 is a radial cross-sectional view taken along section line 6-6 ofthe intermediate member illustrated in FIG. 5.

FIG. 7 is an enlarged cross-sectional view of an alternative embodimentof a connector member with suture material and two laterally disposedferrules in accordance with the present invention.

FIG. 8 is a plan view of an alternative embodiment of a suturing devicewith a needle cartridge for use in accordance with the presentinvention.

FIGS. 9-16 illustrate the use of the suturing device of FIG. 1 to suturevascular tissue.

FIG. 17 is a perspective view of a hollow needle for use in the suturingdevices described herein.

FIGS. 18-20 illustrate the use of the suturing device of FIG. 1 with ahollow needle of FIG. 17.

FIG. 21 is a perspective view of one embodiment of a suture securingdevice for use in the present invention.

FIG. 22 is a perspective view of an alternative embodiment of a suturesecuring device for use in the present invention.

FIG. 23 is a cross-sectional view of one embodiment of a suturing devicewith a needle capture element in accordance with the present invention.

FIG. 24 is an enlarged view in cross section of the distal member of thesuturing device of FIG. 23.

FIG. 25 is an enlarged view in cross section of the distal member of thesuturing device of FIG. 23 with a needle disposed within a receptacle inthe distal member.

FIG. 26 is an enlarged view in cross section of an intermediate memberwith needle engaging projections of an alternative suturing device inaccordance with the present invention.

FIG. 27 is an enlarged view in cross section of the distal memberillustrated in FIG. 26 with a needle disposed in the receptacle.

FIG. 28 is a plan view of an alternative embodiment of a suturing devicewith a needle cartridge for use in accordance with the presentinvention.

FIGS. 29-34 illustrate methods of use of the suturing device accordingto the present invention.

FIG. 35 is a perspective view of one embodiment of a suture securingdevice for use in the present invention.

FIG. 36 is a perspective view of an alternative embodiment of a suturesecuring device for use in the present invention.

FIG. 37 is a perspective view of one embodiment of a suturing devicewith an articulating foot according to the present invention.

FIG. 38 is an enlarged fragmentary view of the intermediate member ofthe suturing device illustrated in FIG. 37.

FIG. 39 is a plan view of the suturing device illustrated in FIG. 37.

FIG. 40 is a cross-section view taken on line 40-40 of the suturingdevice illustrated in FIG. 39.

FIG. 41 is a longitudinal cross-sectional view along section 41-41 ofthe suturing device illustrated in FIG. 40 illustrating the intermediatemember with the articulating foot in a non-deployed position.

FIG. 42 is a fragmentary cross-section view of the suturing deviceillustrated in FIG. 37 with the foot in a first, non-deployed position.

FIG. 43 is a fragmentary cross-section view of the suturing deviceillustrated in FIG. 37 illustrating the intermediate member with thearticulating foot in a second or deployed position.

FIGS. 44-47 illustrate use of the suturing device of FIG. 37.

FIG. 48 is a perspective view of one embodiment of a suture securingdevice for use in the present invention.

FIG. 49 is a perspective view of an alternative embodiment of a suturesecuring device for use in the present invention.

FIG. 50 is a perspective view of one embodiment of a suturing devicewith a needle capture element in accordance with the present invention.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 is an exploded view of one embodiment of a suturing device 10 forsuturing vascular vessels in accordance with the present invention.Device 10 includes a proximal member 12, a distal member 14, and anintermediate member 16 located therebetween. Device 10 includes one ormore needles 18 advanceable through a portion of the proximal and distalmembers. A needle pusher 26 can either push or engage needle 18 toadvance it through a channel 24 in the proximal member and throughvascular tissue adjacent the puncture wound. In one form, suturematerial can be attached to needle 18 which is then advanced in a distaldirection through tissue. In other forms, suture material can be locatedwithin distal member to be snared by a needle to be withdrawn in aproximal direction through tissue. A second needle and subsequentneedles can be similarly configured and manipulated to place suturesthrough tissue adjacent a puncture wound in a vascular vessel. Thesuture material(s) threaded through the vascular tissue can be drawntaut closing the puncture wound. A surgical knot or other suturesecuring device can complete the wound closure.

As used herein, the term “proximal” refers to a direction toward thesurgeon and away from the patient or a location closer to the surgeon,while the term “distal” refers to a direction towards the patient andaway from the surgeon or a location closer to the patient.

Proximal member 12 is provided as an elongated portion with asubstantially cylindrical or oval radial cross section. Member 12includes a first end of sufficient dimensions to be readily grasped bythe surgeon to manipulate the device during the procedures. Proximalmember 12 can also include a gripping portion to facilitate handlingduring the surgical procedure. Needle channel 24 runs longitudinallyalong at least a portion of proximal member. In one embodiment, channel24 extends along the entire length of proximal member from a first endpositioned proximal to the surgeon to a second end adjacent tointermediate member 16. In this embodiment, one or more needle(s) 18 andneedle pusher(s) 26 can be inserted into and retrieved from channel 24at the first end. In other embodiments, channel 24 extends only partlythrough the proximal member 12. Needle channel 24 can be centrallylocated along proximal member 12. In preferred embodiments, proximalmember 12 includes a single needle channel 24 through which one, two,three, or more needles can be advanced. Alleviating multiple needlechannels within the suturing device provides a more compact member,which can be particularly advantageous for subcutaneous procedures.

Channel 24 is sized and dimensioned to allow one or more needles 18 tobe advanceable therethrough and into vascular tissue around the puncturewound. Furthermore, channel 24 can be either partly or completelyencased within the body of proximal member 12. However, in a preferredembodiment, channel 24 is not encased within the body of proximal member12. Rather, channel 24 is provided as a slot formed into the surface ofproximal member 12. Preferably the slot is configured to retain one ormore needles within the slot. For example, the slot can be formed tohave an opening at the exterior surface of proximal member that isnarrower than the diameter of the needles (and optionally the pusher)while the internal portion or diameter of the slot can be dimensioned topermit facile movement of the needle therethrough. An exit opening islocated at the distal end of channel 24.

Proximal member 12 includes a blood return line or lumen 25 thatterminates in a fitting 27, for example, a luer lock that can be matedto a syringe. Alternatively, blood return lumen 25 can terminate in avalve or shunt to control and stop blood flow therethrough. It ispreferable that blood return lumen 25 be transparent to allow visibleobservation of blood originating from inside the vascular vessel. Thiscan facilitate proper placement of the device for suturing.

Distal member 14 is sized and/or configured to be received within anopening or wound leading to a lumen of a patient's vascular vessel.Therefore, it is preferable that at least distal member 14 be formed ofa flexible or elastomeric material that is biocompatible—particularlywith blood. In a preferred embodiment, proximal member 12 and distalmember 14 define a longitudinal axis. In additional embodiments, distalmember 14 can be coated or impregnated with a lubricant, bioactiveagent, such as an anticoagulant material, and the like. In certainembodiments, distal member 14 is composed of a biocompatible polymericmaterial commonly used for catheters, such as silicone rubber,polyolefin polyurethane, polytetrafluoroethylene, and the like.

FIG. 1A illustrates one or more lengths of suture material 20 that canbe included in receptacle 22 of distal member 14 in accordance with oneembodiment of the present invention. The lengths of suture material 20can include one or more fittings 21, 23, for example, a ferrule or cuffof porous or mesh material, to engage the needle.

Distal member 14 includes a receptacle 22. Receptacle 22 is sized toreceive at least one length of suture material 20 with a correspondingfitting 21, as specifically shown in FIG. 2. Preferably receptacle 22 issized to hold one, two, or more separate lengths of suture material.Each length of suture material can include either a single fitting 21 ortwo fittings—one on each end. In a preferred embodiment, receptacle 22is provided as a multi-stage or tapered recess. Each fitting ispositioned within a receptacle to allow for ready deployment andsubsequent engagement with needle 18 advancing from channel 24 inproximal member 12. Preferably the fittings are releasably retained sothat needles advancing into receptacle 22 can sequentially engage thefittings without forcing that fitting distally further or deeper intothe receptacle. In one form, this can include a shoulder or abutment 30extending from the internal wall of receptacle 22 to abut a distal endof a fitting. In other embodiments, this can include configuring theinternal dimensions of receptacle 22 to taper or decrease in diameter inthe distal direction. In other embodiments, a multi-stage receptacle 22or stepped internal walls receptacle 22 can prevent movement of thefittings in the distal direction. In still other embodiments, thefittings are loaded within the receptacle 22 to bear against the suturematerial which is packed within the end of receptacle 22. In thisembodiment, the bulk of suture material in receptacle 22 can inhibit orprevent distal movement of the fittings upon initial engagement withneedle 18.

FIGS. 3 and 4 illustrate a portion of needle 18 and fitting 21 in theform of a ferrule 44 . . . . Needle 18 includes a distal tip 32 and aproximal end 34. Distal tip 32 is configured as a tissue piercing pointor a barbed tip. Needle 18 is configured to grab suture material locatedin the lumen of the vessel and withdraw the suture material throughvascular tissue. In the preferred embodiment, distal tip 32 isconfigured to securely engage with ferrule 44 which, in turn, isattached to a length of suture. Ferrule 44 can be extremely small,having roughly a diameter similar to or slightly larger than that of thesuture material 20. Alternatively, ferrule 44 can have approximately thesame diameter as the diameter of needle shaft 35. In this embodiment,distal tip 32 has a smaller diameter to allow it to be received insideferrule 44. Distal needle tip 32 includes at least one recessedengagement surface or shoulder 37 configured to matingly engage with acorresponding engagement surface 38 provided on or in ferrule 44. In oneform, the engagement surface is a tab extending into the interior offerrule 44. In other embodiments, the engagement surface is a shoulderextending radially inward in ferrule 44 or a groove partly or completelyencircling an interior wall of ferrule 44. Fitting 23 also may be in theform of a ferrule 46 shown in FIGS. 5 and 6. Ferrule 46 may have similarneedle retention features.

FIGS. 5 and 6 show that the ferrules 44 and 46 need not be the samesize—particularly the same diameter. In this regard certain advantagescan be gained by providing the proximally located ferrule 44 with adiameter greater than that of the distally located ferrule 46. Forexample, this will allow sufficient room for the suture materialextending from ferrule 44 to extend along side of ferrule 46—betweenferrule 46 and an internal wall section of receptacle 22. In otherconsiderations, the suture material from the proximally located ferrule44 can be disposed between that ferrule and the next distally locatedferrule 46. Ferrules 44 and 46 can also be tapered or “streamlined” toallow them to be readily pulled through a small needle puncture site intissue as described below.

In one embodiment, the length of suture material which is attached tothe different ferrules on each end can include different color codingsfor the different ends. This allows a surgeon to differentiate whichsutures are attached to which ferrules to facilitate tying suitableknots to close puncture 96 in the vessel.

One or more of needles 18 and ferrules 44, 46 for use in the presentinvention can be provided as substantially described in U.S. Pat. No.6,136,010 issued to Modesitt et al. and/or U.S. Pat. No. 6,368,334issued to Sauer, which are incorporated herein by reference in theirentirety.

Proximal end 34 of needle 18 can be free and configured to be handled bya surgeon. Alternatively, proximal end 34 can be engageable or securedto a needle pusher 26 shown in FIG. 2. In yet another embodiment,proximal end 34 can be integral or formed as a single unit with needlepusher 26. In either embodiment, needle pusher 26 is sized to bepositioned within channel 24 and can further include a projection 36 toallow the surgeon to advance the needle pusher/needle combination alongchannel 24. In a preferred embodiment, needle pusher 26 is configuredsuch that the surgeon can sequentially advance needle 18 in a proximaldirection towards the patient and in a distal direction away from thepatient.

Referring back to FIG. 2, distal member 14 can also include a lumen 39extending at least partially therethrough. Preferably, lumen 39 isseparate from receptacle 22. Lumen 39 can be provided to receive orfollow a guide wire left in place after a particular diagnostic ortreatment procedure. This can allow the facile insertion of distalmember 14 into the patient's vascular vessel. In a preferred embodiment,an opening 40 receives a guide wire (not shown) that extends throughlumen 39 and exits through a side opening 41 of distal member 14 topermit the guide wire to extend out without interfering with theneedles, needle path, or suture material. The guide wire can be removedafter placement of the suture device or left in as desired or consideredmedically prudent by the surgeon.

Intermediate member 16 is located between proximal member 12 and distalmember 14. Intermediate member 16 defines a tissue-receiving area 45. Inthe illustrated embodiment, intermediate member is configured to includean arcuate portion or a crooked section. The arcuate portion or crookthus defines a concave interior surface 47 and a convex exterior surface48. Intermediate member 16 includes a first opening 50 providing accessfrom the channel 24 to the tissue receiving area 45 and a second opening52 from the receptacle 22 providing to the tissue receiving area 45.Preferably, first and second openings 50 and 52 are linearly or axiallyaligned. Intermediate member 16 can be composed of a biocompatiblematerial that is substantially resistant to deformation and thereforecan maintain the linearity between channel 24 and receptacle/chamber 22and the respective first and second openings 50 and 52. Examples ofsuitable materials include TEFLON, NYLON, polyamids, and the like.

Intermediate member 16 also includes means and structure for reliablepositioning of the device during surgery to facilitate closing thevascular puncture wound with sutures. Part of the positioning structureincludes an opening 54 providing fluid communication to blood returnlumen 25 in proximal member 12. In a preferred embodiment, opening 54 islocated on a portion of the convex surface of the crook opposite thetissue receiving area 45. When the distal member 14 of the device issuitably positioned within the lumen of a vascular vessel, opening 54 isalso located in the interior of the lumen. This permits blood from thevessel to enter blood return lumen 25, which can then be visiblyobserved by the surgeon. If blood is not observed in blood return lumen25, then the distal member may not have been inserted to a sufficientdepth into the lumen of the vascular vessel.

Additionally, a ridge or stop 56 extends from the concave surface intothe tissue receiving region. Stop 56 is configured to bear againstvascular tissue adjacent the puncture wound. In a preferred embodiment,first opening 50 is adjacent stop 56 permitting needle 18 to piercetissue adjacent thereto. Stop 56 is sized to bear against the vasculartissue and avert further insertion of the device 10 into the vascularvessel. When provided together, stop 56 and opening 50 with blood returnlumen 25 cooperate to ensure accurate placement of the suturing devicein the patient's vascular vessel. Ridge or stop 56 can also extendradially about the entire circumference of intermediate member 16.

FIG. 7 is a cross-sectional view of an intermediate member 70 of analternative embodiment of a suture device. In this embodiment, fittings72 and 73 are positioned radially or laterally displaced from each otherin receptacle 74. A first fitting 72 is positioned axially aligned withsecond opening 75 in the distal member 76. A biasing element such as aleaf spring 77 can also be positioned in receptacle 74 to urge secondfitting 73 into axial alignment with opening 75 once first fitting 72has been displaced. Biasing element 77 can be a leaf spring asillustrated, an elastomeric projection, or other known biasing materialsuitable to urge fitting 72 into alignment as desired.

FIG. 8 is a perspective view of another embodiment of a suturing device80 with a needle cartridge in accordance with the present invention.Device 80 includes a proximal member 81, a distal member 82, and anintermediate member 83 therebetween. Proximal member 81 includes aneedle cartridge 84 slidably mounted in body 85. Needle cartridge 84 caninclude a plurality of needle slots, for example one, two, three, ormore slots 86 a, 86 b, 86 c . . . , each for a separate needle.Typically, the number of needles in needle cartridge 84 will coincidewith the number of fittings with suture material in the receptacle indistal member 82. Each needle in needle cartridge 84 is individuallyadvanceable through a central needle channel 87 along a length ofproximal member 81. Needle cartridge 84 is laterally displaceable withinbody 85 to axially align the selected needle slot 86 a, 86 b, 86 c . . .with a single needle channel. If desired, needle cartridge can be biasedto automatically align the successive needle slots with the needlechannel after the preceding needle has been advanced along the channel.Alternatively, suturing device 80, body 120, and/or cartridge 118 caninclude one or more of ratchetings, positive stops, or locks toindividually align the desired needle slot with the channel. In otherembodiments, needle cartridge 84 can be provided as a revolving barrelthat can hold two, three, or more needles in respective needle slotsradially disposed about the barrel. The barrel can be rotatably mountedon or about proximal member 81. Distal member 82 and intermediate member83 can be configured substantially as described above for members 14 and16, respectively.

Referring to FIGS. 9 through 14, use of the suturing device 10, will nowbe described. A puncture wound in a vascular vessel can be suturedclosed using the suturing device 10. Suturing device 10 can be inserteddistally into the vascular vessel. This can be accomplished with orwithout the use of a guide wire. In a procedure where a guide wire hasbeen previously used, suturing device 10 can be threaded onto a guidewire 92 which extends from internal vessel lumen 94 through a puncturewound 96 in vessel 93 and through a portion of the overlying tissue 95to be exposed to the surgeon. In that regard, side opening 41 of lumen39 can be threaded onto guide wire 92 which then extends out throughopening 40. Thus, the flexible portion of distal member 14 can begingerly threaded into the lumen 94 of vessel 93. The distal member 14of device 10 can be positioned within lumen 94 such that intermediatemember 16 engages with a portion of the tissue surrounding puncture 96.Distal member 14 is advanced in a distal direction until blood isobserved in blood return lumen 25. Additionally, when provided, stop 56abuts or bears against the external surface of the vascular vessel. Thiscan be detected by the increased resistance to further advancement ofthe device in the distal direction. Both blood return lumen 25 and stop56 can be used to ascertain that the device has been correctlypositioned within the lumen 94 of the vascular vessel 93 to allowsuturing of puncture 96. It should be noted that observance of blood inneedle channel 24 is an indication that device 10 has been inserted toofar into the lumen such that first opening 50 is exposed to the interioror blood side of vessel 93. If desired, guide wire 92 can then bewithdrawn from lumen 39 and out of vascular vessel 93—if it is no longerneeded for subsequent procedures.

After the distal member 14 is positioned as desired, the vascular tissueadjacent the puncture wound is received within the tissue receiving area45. As noted above, intermediate member 16 provides an essentiallylinear needle pathway between channel 24, receptacle 22, and thevascular tissue in the tissue receiving area 45. Consequently, whenneedle 18 is advanced through channel 24, it pierces the vascular tissueat a first suture site 97 adjacent the puncture wound 96.

FIG. 10 illustrates suturing device 10 at a first suture position withneedle 18 a advancing distally through channel 24 and piercing thevascular tissue of vessel 93 at a first suture site 97 on a first sideof wound 96. From there, needle tip 32 advances into to receptacle 22 toengage in a first ferrule 44. Once engaged with ferrule 44, first needle18 a can then be withdrawn back through opening 52 in distal member 14and through first suture site 97, drawing a length of suture material 20through the vascular tissue in a proximal direction as illustrated inFIG. 1. Preferably the needle path in the proximal direction is the sameas in the distal direction—provided that the suturing device has notbeen moved or dislocated. Needle 18 a, including a length of suturematerial 20, can then be removed from suture device 10. Alternatively,needle 18 a and/or a length of suture material can be retained withsuture device 10 for subsequent retrieval and use in securing the woundclosure.

Thereafter, suture device 10 is rotated into a second suture position asillustrated in FIG. 12. For example, suture device 10 may be rotatedapproximately 180.degree. so that in the second suture position, suturedevice 10 is positioned to operate on a second side of puncture 96diametrically opposite first suture site 97. After ensuring that thesuturing device is correctly positioned, the procedure described abovefor needle 18 a can be followed. At the second suture position, a secondneedle 18 b is distally advanced using a needle pusher, either the sameneedle pusher or a second, different needle pusher, through channel 24to engage in and pierce the vascular tissue 93 received within tissuereceiving area 45 at second suture site 99. Again, needle 18 b isadvanced to enter receptacle 22 and there engage with second ferrule 46as shown in FIG. 13. Withdrawal of the needle pusher concomitantlywithdraws ferrule 46, and a length of suture 20 through second suturesite 99 as shown in FIG. 14. Needle 18 b and the attached ferrule 46 andlength of suture material can be retrieved by the surgeon either by handor received within a slot in the proximal member. Thereafter, ifdesired, the process can be repeated, rotating suturing device 10through about 90.degree. and again, advancing a needle to engage in asubsequent ferrule located in receptacle 22. This process can berepeated as desired and as provided with a number of needles and/orsuture materials with ferrules in receptacle 22. It will be understoodthat in one embodiment, first and second lengths of suture materials aretwo ends of the same suture. In other embodiments, lengths of suturematerial are separate pieces of suture. Thereafter, device 10 can bewithdrawn from the body as illustrated in FIG. 15.

As illustrated in FIG. 16 the lengths of suture material 20 can begathered. The length of suture material can be separated from theneedles. Pulling the lengths of suture material taut closes the wound 96in the vessel 93. In this embodiment, the path of the suture materialpasses through vascular tissue on a first side of the wound into thelumen 94 of the vessel 93, across the wound 96—again in the lumen 94—andthen out through the vascular tissue 93 on a second or opposite side ofthe wound. A surgical knot can be tied securing the wound closure. Aknot pusher, for example, the knot pushers described in U.S. Pat. No.5,304,184 issued to Hathaway et al., U.S. Pat. No. 5,746,755 issued toWood et al., and U.S. Pat. No. 6,132,439 issued to Kontos, can be usedto advance the loosely tied knot to the exterior surface of the vascularvessel. In selected embodiments, the surgeon can then tie a suitablesurgical knot using the respective lengths of suture material to closethe puncture wound 96. In other embodiments, the suture material can besecured using a variety of knot replacement technologies such as thatdisclosed in U.S. patent application Ser. No. 10/164,606 (US PatentPublication No. 2003/0229377) and in Ser. No. 10/305,923 (US PatentPublication No. 2004/0102809) and depicted in FIGS. 21 and 22. Each ofthe above-noted references are incorporated by reference in theirentirety.

FIG. 17 is a perspective view of one embodiment of a hollow needle 88for use in accordance with the present invention. Needle 88 includes adetachable tip 89, a hollow shaft 90, and a length of suture material91. The length of suture material 91 extends out the proximal end ofhollow needle 88. In one embodiment, one end of the suture material 91is attached to needle tip 89. In this embodiment, the needle tip 89 canbe used to pull suture material 91 through a portion of a suturingdevice or through vascular tissue as discussed more fully below.

FIGS. 18 through 20 illustrate the use of hollow needles with thesuturing device 10. The suturing device 10 is inserted into the vascularvessel as described above and illustrated in FIG. 9. After suturingdevice 10 has been positioned within the lumen 94 as desired, needle 88is advanced in the distal direction through needle channel 24 to piercevascular tissue 93 adjacent the wound 96 in the vessel and then intorecess 22 to engage with a first ferrule 44. Needle 88, the attachedferrule 44, and a length of suture material 20 are withdrawn in theproximal direction back through the needle path through a first suturesite.

Suturing device 10 can be rotated about its longitudinal axis whilemaintaining the distal member within the vascular lumen to a secondsuturing position. FIG. 19 illustrates the advancement of hollow needle88 along channel 24. Hollow needle 88 can pierce vascular tissue 93 at asecond suture site. Needle tip 89 can then engage with the secondferrule 46 located in receptacle 22. Once engaged to second ferrule 46,needle tip 89 can be separated from shaft 90 by withdrawal of the needleshaft 90 back through the second suture site. The needle shaft can bereceived in or through channel 24. Suture material 91 is then connectedto suture material 20 via ferrule 46 and needle tip 89. Suturing device10 can then be removed from the vascular vessel and eventually from thepatient.

Referring now FIG. 20, suture material 20 and 91 are connected togetherusing second ferrule 46 and needle tip 89. The connected suture materialcan be pulled in either direction by 1) pulling on suture material 20 inthe distal direction to draw ferrule 46, needle tip 89, and a portion ofsuture material 91 through the second suture site, or 2) pulling onsuture material 91 in the distal direction to draw ferrule 46, needletip 89, and a portion of suture material 20 through the second suturesite. In yet other embodiments, the free ends of suture material 20 and91 can be pulled taut to close the vascular wound. Preferably in thisembodiment both of needle tip 89 and ferrule 46 (as well as the suturematerials) are composed of a biodegradable material to biodegrade.Biodegradable materials for the ferrule, needle tips, and suturematerial are well known in the art and these materials are useful toprepare the components of the present invention.

FIG. 21 is a perspective view of a suture securing device 102 for use inthe present invention. Suture clamping device 102 is described andillustrated in US Patent Publication No. 2004/0102809 which isincorporated herein by reference. In use, device 102 can secure ends ofone, two, three or more lengths of suture material. Two lengths ofsuture material 104 a and 104 b are illustrated with device 102. Thelengths of suture material are threaded into the flexible elements 105 aand 105 b which are then locked or fixed together clamping the suturematerial therein.

FIG. 22 shows another embodiment of suture clamping devices 106 a and106 b for use in the present invention. Devices 106 a and 106 b aredescribed in US Patent Publication No. 2003/0229377 which isincorporated herein by reference in its entirety. Devices 106 a and 106b cooperate by separately clipping onto a selected length of suturematerial 104 a or 104 b which have previously pulled taut to close thewound 96 or complete the surgical procedure. The devices prevent thesuture material from regressing back through the sutured tissue.

FIG. 23 shows a suturing device 110 for suturing vascular vessels inaccordance with the present invention. Device 110 includes a proximalmember 112, a distal member 114, and an intermediate member 116 locatedtherebetween. Device 110 includes one or more needles 118 a, 118 b, 118c . . . disposable within needle channel 124 of proximal member 112.Each of needles 118 a, 118 b, 118 c . . . can include a length of suturematerial 120 a, 120 b, 120 c . . . secured to the proximal end of theneedles. Needle pusher 126 can be used to advance the needles 118 a, 118b, 118 c, . . . through channel 124 out through first opening 150 into atissue receiving area 145 defined by intermediate member 116.Preferably, proximal member 112 and/or distal member 114 define alongitudinal axis and (either/both) is/are essentially linear about thisaxis. In one embodiment, the intermediate member 116 can be configuredto deviate from the linearity defined by either the proximal member (orthe distal member). First opening 150 and second opening 152 inintermediate member can be axially aligned to permit needles 118 a, 118b, 118 c . . . to travel in an essentially linear needle path thatextends through tissue received within tissue receiving area 145. In oneform, suture material can be attached to the needle 118 a. The needle isthen advanced in a distal direction through tissue. A second needle 118b (and subsequent needles) can be similarly configured and manipulatedto place sutures about tissue adjacent a puncture wound in a vascularvessel. The suture material(s) threaded through the vascular tissue canbe drawn taut closing the puncture wound. A surgical knot or othersuture securing device can complete the wound closure.

As used herein, the term “proximal” refers to a direction toward thesurgeon and away from the patient or a location closer to the surgeon,while the term “distal” refers to a direction towards the patient andaway from the surgeon or a location closer to the patient.

Proximal member 112 is provided as an elongated portion and can exhibita substantially cylindrical or oval radial cross section. Member 112includes a first end of sufficient dimensions to be readily grasped bythe surgeon to manipulate the device during the procedures. Proximalmember 112 can also include a gripping portion 135 to facilitatehandling during the surgical procedure. Needle channel 124 runslongitudinally along at least a portion of proximal member 112. In oneembodiment, channel 124 extends along the entire length of proximalmember from a first end positioned proximal to the surgeon to a secondend adjacent to intermediate member 116. In this embodiment, one or moreneedle(s) 118 a, 118 b, 118 c, . . . and a needle pusher 126 and grip136 can be inserted into and retrieved from channel 124 at the firstend. In other embodiments, channel 124 extends only partly through theproximal member 112. Needle channel 124 can be centrally located alongproximal member 112. In preferred embodiments, proximal member 112includes a single needle channel 124 through which one, two, three, ormore needles can be advanced. Alleviating multiple needle channelswithin the suturing device provides a more compact member, which can beparticularly advantageous for subcutaneous procedures.

Channel 124 is sized and dimensioned to allow one or more needles 118 a,118 b, 118 c . . . to be advanceable therethrough and into vasculartissue around the puncture wound. Furthermore, channel 124 can be eitherpartly or completely encased within the body of proximal member 112.However, in a preferred embodiment, channel 124 is not encased withinthe body of proximal member 112. Rather, channel 124 is provided as aslot formed into the surface of proximal member 112. Preferably the slotis configured to retain one or more needles within the slot. Forexample, the slot can be formed to have an opening at the exteriorsurface of proximal member that is narrower than the diameter of theneedles (and optionally the pusher 126) while the internal portion ordiameter of the slot can be dimensioned to permit facile movement of theneedle therethrough. An exit opening is located at the distal end ofchannel 124.

Proximal member 112 includes a blood return line 125 that terminates ina fitting 127, for example, a luer lock that can be mated to a syringe.Alternatively, line 125 can terminate in a valve or shunt to control andstop blood flow therethrough. It is preferable that blood line 125 allowvisible observation of blood originating from inside the vascularvessel. This can facilitate proper placement of the device for suturing.

Referring additionally to FIGS. 24 and 25, distal member 114 is sizedand/or configured to be received within a lumen of a patient's vascularvessel similar to distal member 114. In additional embodiments, distalmember 14 can be coated or impregnated with a lubricant, bioactiveagent, such as an anticoagulant material, and the like. In certainembodiments, it is preferable that at least distal member 14 be formedof a flexible or elastomeric material that is biocompatible—particularlywith blood. For example, distal member 14 can be composed of abiocompatible polymeric material commonly used for catheters, such assilicone rubber, polyethylene, polyolefin, polyurethane,polytetrafluoroethylene, polyvinyl chloride and the like.

Distal member 114 includes a receptacle 122 sized and configured toreceive and retain at least one needle 118 a, and preferably two or moreneedles 118 b, 118 c . . . . Preferably, receptacle 122 is sized toretain one or more needles such that the proximal end of each of theneedles does not extend beyond opening 152.

A needle catching element 123 located in receptacle 122 is provided toengage with at least a portion of needles 118 a, 118 b, 118 c . . . .Element 123 can be configured as a plug of pierceable material. Thematerial can be any biocompatible material pierceable with a surgicalneedle. Representative examples include materials such as siliconerubber, polyethylene, or polyurethane. In certain embodiments, the plugof material is composed of the same material as that used to form thedistal member. The plug of material can be friction fit, adhesivelybound, or mechanically retained inside receptacle 122. In otherembodiments, the plug of material can include a molded flap extendingfrom an interior wall portion of receptacle 122. In still otherembodiments, the needle catching element 123 can be integral with, oralternatively define, a bottom wall portion of receptacle 122. Needlecapture element 123 can completely close off or block receptacle 122. Inother forms, element 123 need not completely block receptacle 122.

Referring back to FIG. 23, distal member 14 can also include a lumen 139extending at least partially therethrough. Preferably, lumen 139 isseparate from receptacle 122. Lumen 139 can be provided to receive orfollow a guide wire left in place after a particular diagnostic ortreatment procedure. This can allow the facile insertion of distalmember 114 into the patient's vascular vessel. In a preferredembodiment, lumen 139 exits through a side of distal member 114 atopening 140 to permit a guide wire (not shown) to extend out withoutinterfering with the needles, needle path, or suture material. The guidewire can be removed after placement of the suture device or left in asdesired or considered medically prudent by the surgeon.

Intermediate member 116 is located between proximal member 112 anddistal member 114. Intermediate member 116 defines a tissue-receivingarea 145. In the illustrated embodiment, intermediate member isconfigured to include an arcuate portion or a crooked section. Thearcuate portion or crook can defines a concave interior surface 147 anda convex exterior surface 148. Intermediate member 116 includes a firstopening 150 providing access from the channel 124 to the tissuereceiving area 145 and a second opening 152 from the receptacle 122providing to the tissue receiving area 145. Preferably, first and secondopenings 150 and 152 are linearly or axially aligned. Intermediatemember 116 can be composed of a biocompatible material that issubstantially resistant to deformation and therefore can maintain thelinearity between channel 124 and receptacle/chamber 122 and therespective first and second openings 150 and 152. Examples of suitablematerials include TEFLON, NYLON, polyamids, and the like.

Intermediate member 116 also includes means and structure for reliablepositioning of the device during surgery to facilitate closing thevascular puncture wound with sutures. Part of the positioning structureincludes an opening 154 providing fluid communication to blood returnline 125 in proximal member 112. In a preferred embodiment, opening 154is located on a portion of the convex surface 148 of the intermediatemember 116 opposite the tissue receiving region 145. In use, with thedistal member of the device suitably positioned within the lumen of avascular vessel, opening 154 is also located in the interior of thelumen. This permits blood from the vessel to enter blood return line125, which can then be visibly observed by the surgeon. If blood is notobserved in blood return line 125, then the distal member may not havebeen inserted to a sufficient depth into the lumen of the vascularvessel.

Additionally, a ridge or stop 156 extends from the concave surface intothe tissue receiving region. Stop 156 is configured to bear againstvascular tissue adjacent the puncture wound. In a preferred embodiment,first opening 150 extends through a portion of stop 56 permitting needle118 to pierce tissue adjacent thereto. Stop 156 is sized to bear againstthe vascular tissue and avert further insertion of the device 110 intothe vascular vessel. When provided together, stop 156 and opening 150with blood return line 125 cooperate to ensure accurate placement of thesuturing device in the patient's vascular vessel. Ridge or stop 156 canalso extend radially about the entire circumference of intermediatemember 116.

FIG. 24 shows needle 118 a entering opening 152 in distal member 114 andtraversing receptacle 122 in response to distal movement of needlepusher 126.

FIG. 25 illustrates the capture of needle 118 a within receptacle 122.Element 123 is positioned in receptacle 122 to engage with at least thedistal tip 132 of needle 118 a. Preferably element 123 is positioned ata location or depth within receptacle 122 such that the proximal end 134of a captured needle does not extend out of opening 152 of receptacle122 to snag on any tissue or other structure as the suturing device ismanipulated and eventually removed from the vascular vessel.

FIGS. 26 and 27 illustrate partial views of an alternative embodiment ofa suturing device 210 with a needle capture element 223. The illustrateddistal and intermediate members 214 and 216 are configured similarly todistal and intermediate members 114 and 116. However, distal member 214includes a receptacle 222. Receptacle 222 is configured to receive oneor more needles therein. Needle capture element 223 comprises at leastone projection 229 and preferably at a second projection 231 eachextending radially inwardly from an interior wall portion 233. It willbe understood that receptacle 222 can include a plurality of projectionssimilarly configured as illustrated and/or described for projections 229and 231. The projections 229 and 231 are configured to engage andcapture or retain one or more needles 218 within the interior ofreceptacle 222. The projections 229 and 231 can frictionally engage thetips or sides of inserted needles to prevent their accidentaldislodgement during surgical manipulation. In the illustratedembodiment, projections 229 and 231 are configured as a plurality ofpaired leaves projecting from the interior wall portion 233 ofreceptacle 222. It will be understand that in other embodiments, theleaves need not be paired; or, if paired, the leaves can be axiallyand/or radially offset from each other. In still other embodiments,projections 229 and 231 can be configured as protuberances, bumps,ridges, or threads extending from an internal wall portion of receptacle222 to engage and retain one or needles 218 therein. Further, one ormore of needles 118 a, 118 b, and 118 c can include a recessed surfaceconfigured for engagement with at least one of the projections 229 and231. For example, a needle can be configured with a barbed point oralternatively with a tip similar to a tip as described in connectionwith FIGS. 1-22 above.

Referring specifically to FIG. 27, a needle 218 with a length of suturematerial 220 is illustrated as captured within lumen 222. As can beobserved in the illustration, a plurality of projections 229 and 231frictionally engage with the sides of the inserted needle 218.Preferably, the projections 229 and 231 are angled in the distaldirection from their point of connection to wall 233 of receptacle 222.This causes the frictional engagement resisting needle movement in aproximal direction to be greater than the frictional engagementresisting a needle movement in a distal direction. This engagementeffectively prevents the inserted needle 218 from being dislodged bymanipulation of suturing device 210 within the patient or uponwithdrawing the suturing device from the vascular vessel.

FIG. 28 is a perspective view of another embodiment of a suturing device80 with a needle cartridge in accordance with the present invention.Device 80 includes a proximal member 81, a distal member 82, and anintermediate member 83 therebetween. Proximal member 81 includes aneedle cartridge 84 slidably mounted in body 85. Needle cartridge 84 caninclude a plurality of needle slots, for example, two, three, four, ormore slots 86 a, 86 b, 86 c . . . , each for a separate needle. Eachneedle in needle cartridge 84 is individually advanceable through acentral needle channel along a length of proximal member 81. Needlecartridge 84 is slidably disposed within body 85 to axially align theselected needle slot 86 a, 86 b, 86 c . . . with a single needle channel87. If desired, needle cartridge 84 can be biased to automatically alignthe successive needle slots with the needle channel after the precedingneedle has been advanced along the channel. Alternatively, suturingdevice 80, body 85, and/or cartridge 84 can include one or more ofratchetings, positive stops, or locks to individually align the desiredneedle slot with the channel. In other embodiments, needle cartridge 84can be provided as a revolving barrel that can hold two, three, or moreneedles in respective needle slots radially disposed about the barrel.The barrel can be rotatably mounted on or about proximal member 81.Distal member 82 and intermediate member 83 can be configuredsubstantially as described above for members 114 and 116, respectively.

FIGS. 29 through 34, illustrate the use of suturing device 10 forclosure of a puncture wound 96 in a vascular vessel 93. A puncture woundin a vascular vessel can be sutured closed using the suturing device110. Suturing device 110 can be inserted distally into the vascularvessel. This can be accomplished with or without the use of a guidewire. In a procedure where a guide wire has been previously used,suturing device can be threaded onto a guide wire 92 which extends frominternal vessel lumen 94 through vessel 93 and a portion of theoverlying tissue 95 to be exposed to the surgeon. In that regard,opening 140 of lumen 139 can be threaded onto guide wire 92 which thenextends out through opening 140. Thus, the flexible portion of distalmember 114 can be gingerly threaded into the lumen 94 of vessel 93. Thedistal member 114 of device 110 can be positioned within lumen 94 suchthat intermediate member 116 engages with a portion of the tissuesurrounding puncture 96. Distal member 114 is advanced in a distaldirection until blood is observed in blood return line 125.Additionally, when provided, stop 156 abuts or bears against theexternal surface of the vascular vessel. This can be detected by theincreased resistance to further advancement of the device in the distaldirection. Both blood return line 125 and stop 156 can be used toascertain that the device has been correctly positioned within the lumen94 of the vascular vessel 93 to allow suturing of puncture 96. It shouldbe noted that observance of blood in needle channel 124 is an indicationthat device 110 has been inserted too far into the lumen 94 such thatfirst opening 150 is exposed to the interior or blood side of vessel 93.If desired, guide wire 92 can then be withdrawn from lumen 139 and outof vascular vessel 93—if it is no longer needed for subsequentprocedures.

After the distal member is positioned as desired, the vascular tissueadjacent the puncture wound is received within the tissue receiving area145. As noted above, intermediate member 116 provides an essentiallylinear needle pathway between needle channel 124, receptacle 122, andthe vascular tissue in the tissue receiving area 145. Consequently, whenneedle 118 a is advanced through channel 124, it pierces the vasculartissue 93 at a first suture site 97 adjacent the puncture wound 96.

FIG. 30 illustrates suturing device 10 at a first suture position.Intermediate member 116 provides an essentially linear needle pathwaybetween channel 124 and receptacle 122. A first needle 118 a advancingthrough channel 124 using needle pusher 126 pierces vascular tissue intissue receiving area 145 at the first suture site 97. Needle 118 atrails a length of suture material 120 a pulling it through the vascularat suture site 97 adjacent wound 96. From there, needle tip 132 isadvanced into to receptacle 122 to engage needle capture element 123.Thereafter, needle 118 a and optionally a portion of the suture material120 are inserted into receptacle 122 where at least a portion of theneedle 118 a engages with needle capture element 123. Needle captureelement 123 reliably retains needle 118 a within receptacle 122 duringthe rest of the suturing procedure or until the surgeon decides towithdraw the needle.

As shown in FIG. 31 suturing device 110 is rotated into a second sutureposition. Suture device 110 can be rotated approximately 180.degree. sothat in the second suture position, suture device 110 is positioned tooperate on a second side of wound 96 diametrically opposite first suturesite 97.

FIG. 32 illustrates suturing device 110 in the second suture position. Asecond needle 118 b can be advanced through or along receptacle 122using the needle pusher 126, either the same needle pusher or a second,different needle pusher. Needle 118 b exits first opening 150 to piercevascular tissue received in the tissue receiving area 145 at a secondsuture site 100. Continuing the advancement of needle 118 b through theneedle path draws the attached suture material 120 b through secondsuture site 100 adjacent wound 96. Thereafter at least a portion ofneedle 118 b is captured and retained by needle capture element 123within receptacle 122. If desired, suturing device 110 can again berepositioned to draw suture material through a third and any desiredsubsequent suturing sites. It will be understood that suture material120 a and 120 b can be opposite ends of the same piece of suturematerial. Alternatively, suture material 120 a and 120 b can be twoseparate lengths of suture material.

FIG. 33 illustrates device 110 being removed in a distal direction fromvascular vessel 93. As suture device 110 is withdrawn in the distaldirection, needles 118 a and 118 b remain embedded within the needlecatching element 123 in receptacle 122. Consequently, the attachedlengths of suture material 120 a and 120 b are pulled in a distaldirection through the vascular tissue at the first and second suturesites 97 and 100, respectively and then out through the wound 96. Oneimplementation of the suturing device can be a common length of suturematerial 120 attached to the proximal ends of needles 118 a and 118 b.As illustrated in FIG. 12, the resulting suture path extends from theproximal side of vessel 94 across the wound opening and through thefirst and second suture sites 97 and 100 into the lumen 94. The suturematerial 120 then extends out through wound opening 96 back to thedistal side of vessel 93.

FIG. 34 depicts wound closure. The free ends of the suture material 120can be gathered and a suture knot tied. As with the other proceduresdescribed above, a knot pusher 115, knot boxes as described in WO01/19258, and knot replacement technologies (see FIGS. 13 and 14) can beused to close the wound and secure the suture material. The lengths ofsuture material can be gathered. The length of suture material can beseparated from the needles. Pulling the lengths of suture material tautcloses the wound in the vessel. A surgical knot can be tied securing thewound closure. A knot pusher, for example, the knot pushers described inU.S. Pat. No. 5,304,184 issued to Hathaway et al., U.S. Pat. No.5,746,755 issued to Wood et al., and U.S. Pat. No. 6,132,439 issued toKontos, can be used to advance the loosely tied knot to the exteriorsurface of the vascular vessel. In selected embodiments, the surgeon canthen tie a suitable surgical knot using the respective lengths of suturematerial to close the puncture wound 96.

In other embodiments, the suture material can be secured using a varietyof knot replacement technologies such as that disclosed in U.S. patentapplication Ser. No. 10/164,606 (US Patent Publication No. 2003/0229377)and in Ser. No. 10/305,923 (US Patent Publication No. 2004/0102809) anddepicted in FIGS. 13 and 14. Each of the above-noted references areincorporated by reference in their entirety.

FIG. 35 is a perspective view a suturing securing device 102 for use inthe present invention. Suture securing device 102 is described andillustrated in US Patent Publication No. 2004/0102809 which isincorporated herein by reference. In use device 102 can secure ends ofone, two, three or more lengths of suture material. Two lengths ofsuture material 120 a and 120 b are illustrated with device 102. Thelengths of suture material are threaded into the flexible elements 105 aand 105 b which are then locked or fixed together securing the suturematerial therein.

FIG. 36 is another embodiment of suture securing devices 106 a and 106 bfor use in the present invention. Devices 106 a and 106 b are describedin US Patent Publication No. 2003/0229377 which is incorporated hereinby reference in its entirety. Devices 106 a and 106 b cooperate byseparately clipping onto a selected length of suture material 104 a or104 b which have previously pulled taut to close wound or complete thesurgical procedure. The devices prevent the suture material fromregressing back through the sutured tissue.

FIGS. 37 and 38 illustrate another embodiment of a suturing device 310for use in the present invention. Suturing device 310 includes aproximal member 312, a distal member 314, and an intermediate member 316disposed therebetween. Proximal member 312 is provided as an elongatedportion and can exhibit a substantially cylindrical or oval radial crosssection. Member 312 includes a first end of sufficient dimensions to bereadily grasped by the surgeon to manipulate the device during theprocedures. Proximal member 312 can also include a gripping portion tofacilitate handling during the surgical procedure. A needle channel 324runs longitudinally along at least a portion of proximal member. In oneembodiment, channel 324 extends along the entire length of proximalmember from a first end positioned proximal to the surgeon to a secondend adjacent to intermediate member 316. In this embodiment, one or moreneedle(s) 318 and needle pusher(s) 326 can be inserted into andretrieved from channel 324 at the first end. In other embodiments,channel 324 extends only partly through the proximal member 312. Needlechannel 324 can be centrally located along proximal member 312. Inpreferred embodiments, proximal member 312 includes a single needlechannel 324 through which one, two, three, or more needles can beadvanced. Alleviating multiple needle channels within the suturingdevice provides a more compact member, which can be particularlyadvantageous for subcutaneous procedures.

As used herein, the term “proximal” refers to a direction toward thesurgeon and away from the patient or a location closer to the surgeon,while the term “distal” refers to a direction towards the patient andaway from the surgeon or a location closer to the patient.

Channel 324 is sized and dimensioned to allow one or more needles 318 tobe advanceable therethrough and into vascular tissue around the puncturewound. Furthermore, channel 324 can be either partly or completelyencased within the body of proximal member 312. However, in a preferredembodiment, channel 324 is not encased within the body of proximalmember 312. Rather, channel 324 is provided as a slot formed into thesurface of proximal member 312. Preferably the slot is configured toretain one or more needles within the slot. For example, the slot can beformed to have an opening at the exterior surface of proximal memberthat is narrower than the diameter of the needles (and, optionally, thepusher) while the internal portion or diameter of the slot can bedimensioned to permit facile movement of the needle therethrough. Anexit opening is located at the distal end of channel 324.

Proximal member 312 includes a blood return line 325 that terminates ina fitting 327, for example, a luer lock that can be mated to a syringe.Alternatively, line 325 can terminate in a valve or shunt to control andstop blood flow therethrough. It is preferable that blood line 325 allowvisible observation of blood originating from inside the vascularvessel. This can facilitate proper placement of the device for suturing.

Suturing device 310 comprises a needle cartridge 384 slidably mounted ina body 385 disposed on proximal member 312. Needle cartridge 384 caninclude two, three, four or more needle slots 386 a, 386 b, and 386 c .. . for needles 318 a, 318 b, 318 c, . . . . Each of needles 318 a, 318b, 318 c, in needle cartridge 384 is individually advanceable through acentral needle channel 324 along a length of proximal member 312. Needlecartridge 384 is slidably disposed within body 385 to axially align theselected needle slot 386 a, 386 b, 386 c with needle channel 324. Ifdesired, needle cartridge 384 can be biased to automatically align thesuccessive needle slots with channel 324 after the preceding needle hasbeen advanced. Alternatively, body 385 and/or cartridge 384 can includeone or more of ratchetings, positive stops, or locks to align thedesired needle slot with channel 324. In other embodiments, needlecartridge 384 can be provided as a revolving barrel that can hold two,three, or more needles in respective needle slots radially disposedabout the barrel. The barrel can be rotatably mounted on or aboutproximal member 312.

A needle pusher 326 can either push or engage needle 318 to advance itthrough a channel 324 in the proximal member and through vascular tissueadjacent the puncture wound. In a preferred embodiment, needle pusher326 in conjunction with needle cartridge can be configured such that thesurgeon can sequentially advance needles 318 a, 318 b, and 318 c, . . .in a proximal direction towards the patient.

Each of needles 318 a, 318 b, 318 c, . . . can be attached to a lengthof suture material prior to be being loaded into the needle cartridge.The length of suture material can be attached adjacent to either thedistal end of the proximal end. Preferably, the length of suturematerial is attached adjacent to the proximal end. In anotherembodiment, a single length of suture material is attached at one end toa first needle and at a second end to a second needle. The distal end ofthe needle can be configured to pierce tissue such as vascular tissue.The distal end can taper to a point, be configured as a barbed tip orinclude recessed surfaces to engage in either fittings or the needlecapture elements. Examples of needles with recessed surfaces areillustrated and described in connection with FIGS. 1-22 above andexamples of needles suitable for use with a needle capture element areillustrated and described in connection with FIGS. 23-36 above. Theproximal end 34 of needle can be free and configured to be handled by asurgeon. Alternatively, proximal end can be engageable or secured toneedle pusher 326. In a preferred embodiment, needle pusher 326 isconfigured such that the surgeon can sequentially advance needle 318 ina proximal direction towards the patient and in a distal direction awayfrom the patient.

Suturing device 310 includes distal member 314. In certain embodiments,distal member 314 and/or proximal member 312 is/are linear and define alongitudinal axis. Distal member 314 is sized and/or configured to bereceived within an opening or wound to a lumen of a patient's vascularvessel. Therefore, it is preferable that at least distal member 314 beformed of a flexible or elastomeric material that isbiocompatible—particularly with blood. In additional embodiments, distalmember 314 can be coated or impregnated with a lubricant, bioactiveagent, such as an anticoagulant material, and the like. In certainembodiments, distal member 314 is composed of a biocompatible polymericmaterial commonly used for catheters, such as silicone rubber,polyolefin polyurethane, polytetrafluoroethylene, and the like.

Referring specifically to FIGS. 38 and 39, intermediate member 316 ispositioned between proximal member 312 and distal member 314.Intermediate member 316 is configured to include an arcuate portion or acrooked section 317. An articulating foot 360 is pivotally secured tointermediate member 316 via pivot pin 361. Preferably, foot 360 isadjacent to the tissue receiving area 345 defined by intermediate member316. Lever 362 located axially on proximal member 312 operates toposition foot 360 between a first, non-deployed position to a second,deployed position back again to the first, non-deployed position (seeFIGS. 42 and 43). In certain embodiments, foot 360 is symmetric aboutpivot pin 361 extending in both the proximal direction and the distaldirection the about the same length—measured from the center of pivotpin 361. In other embodiments, foot 360 is asymmetric in thelongitudinal direction in that either the proximal end 363 or the distalend 364 extends further from pivot pin 361 than the other end. It willalso be understood that proximal end 363 can, but need not, be themirror image of distal end 364. (See FIG. 42.)

Intermediate member 316 also includes means and structure for reliablepositioning of the device during surgery to facilitate closing thevascular puncture wound with sutures. Part of the positioning structureincludes an opening 354 providing fluid communication to blood returnline 325 in proximal member 312. In a preferred embodiment, opening 354(see FIG. 40) is located on a portion of the convex surface of the crookopposite the tissue receiving region. In use, with the distal member ofthe device suitably positioned within the lumen of a vascular vessel,opening 354 is also located in the interior of the lumen. This permitsblood from the vessel to enter blood return line 325, which can then bevisibly observed by the surgeon. If blood is not observed in bloodreturn line 325, then the distal member may not have been inserted to asufficient depth into the lumen of the vascular vessel.

Additionally, a ridge or stop 356 extends from the concave surface intothe tissue receiving region. Stop 356 is configured to bear againstvascular tissue adjacent the puncture wound. In a preferred embodiment,first opening 350 extends through a portion of stop 356 permittingneedle 318 to pierce tissue adjacent thereto. Stop 356 is sized to bearagainst the vascular tissue and avert further insertion of the device310 into the vascular vessel. When provided together, stop 356 andopening 354 (with blood return line 325) cooperate to ensure accurateplacement of the suturing device in the patient's vascular vessel. Ridgeor stop 356 can also extend radially about the entire circumference ofintermediate member 316.

Referring now to FIGS. 39 and 40, foot 360 is illustrated as nestingwithin a depression 365 formed in the lateral surface 366 ofintermediate member 316. In this embodiment, foot 360 is configured toprovide or complete the circular or oval radial external profile ofmember 316 to facilitate insertion and use of the device to suturewounds in vascular vessel.

FIG. 41 is a cross-sectional view of suturing device 310. Foot 360 canbe controlled or deployed by lever 362 using cable 367 that extends fromfoot 360 through an interior channel or lumen in member 312 to connectto one end of lever 360. Foot 360 can, but need not, include a biasingelement such as a spring 365 to either urge foot to reside in the firstdeployed position or the second non-deployed position. As illustrated,spring 365 urges lever 362 and foot 360 to a non-deployed position. Itwill be understood that cable 367 can also extend along side of member312 without requiring a separate channel or lumen.

FIG. 42 illustrates intermediate member 316 with foot 360 in anon-deployed position. Movement of lever 362 causes foot 360 to rotateabout pin 361 to a deployed position to support the vascular tissue frominside the vessel lumen as illustrated in FIG. 43. It should be apparentto those skilled in the art that a variety of mechanicalinterconnections may be used to translate the movement of lever 362 intorotation of foot 360 about end 361. In addition to the cable connection367, it may be possible to employ a rack which engages a cog on foot 360so that when the rack is displaced longitudinally the foot 360 rotatesfrom the non-deployed to the deployed condition.

FIGS. 44 through 47 illustrate use of suturing device 310 in accordancewith the present invention. Distal end 314 of suturing device 310 can beinitially inserted into a vascular vessel 94. For this procedure it willbe understood that device 310 includes the blood return line 325,opening 352 and stop 356 for device 10 that operate in cooperation toensure accurate placement of the suturing device in the patient'svascular vessel. However for the purposes of clarity, these elementshave not been illustrated in the present drawing.

Once distal member 314 and at least a portion of intermediate member 316have been inserted into the vascular vessel as desired, foot 360 can bedeployed. In certain embodiments, intermediate member 316 is insertedsufficiently deeply (distally) into the lumen 93 of vessel 94 so thatthe foot 360 is completely enveloped within the interior of lumen 93 tofacilitate deployment of foot 360. This positioning allows faciledeployment of foot 360 such at the tissue engaging surfaces 368 and 369of ends 363 and 364, respectively readily support and bear against inneror distal vascular tissue adjacent the wound 96 without catching onvascular tissue surrounding the wound. Deployment lever 362 on proximalmember 312 can be pivotally rotated urging the cable 367 to deploy foot360. Once foot 360 has been fully deployed, the suturing device 310 canbe withdrawn in the proximal direction, if necessary, to allow the uppersurfaces 368 and 369 of the foot to support and even exert slightpressure on the internal tissue of the vascular vessel as shown in FIG.45. Thereafter, a needle 318 a can be advanced though a needle channel324 in proximal member 312 using needle pusher 326 to pierce vasculartissue adjacent the wound 96 at a first puncture site 97 and intoreceptacle 322. Needle 318 a can remain within receptacle 322 duringfurther manipulation of the device during wound closure.

Referring now to FIG. 46, suturing device 310 can be rotated about itslongitudinal axis to a second suturing position. In general, the sameprocedure as described above can be employed for the present embodiment.However, slight modifications of the procedure can facilitate the use ofthe present device. First distal member 314 need not be removed orcompletely removed from the lumen 94 of vessel 93. However, it may bepreferable to retract foot 360 to the non-deployed position prior torotation of the device to the second suturing position. This can reducethe risk that foot 360 will exert unnecessary force and/or torque on thevascular tissue, which could cause injury such as tears or overextension of the tissue. Once the device is repositioned at the secondsuture position, foot 360 can be re-deployed using lever 362 asdescribed above.

As illustrated in FIG. 46, a second needle 318 b can be advanced throughthe needle channel 324 using needle pusher 326 to pierce vascular tissueat a second puncture site 99. Second needle 318 b can be furtheradvanced into receptacle 322.

After the first and second needles 318 a and 318 b have pulled suturematerial through the vascular tissue, the suturing device 310 can bewithdrawn from the vessel. This results in a suture path that extends ina distal direction through the wound in the vessel to a first suturesite in the vascular tissue; out through the first suture site in aproximal direction; across the wound on the proximal side of the tissueto a second suture site; then in a distal direction through the secondsuture site back into the lumen of the vessel and from there back out inthe proximal direction through the wound as illustrated in FIG. 47. Ifneedles 318 a and 318 b have a single piece of suture material 320connected to their proximal end; the suture material illustrated in FIG.11 is a single strand with two ends extending through the puncture wound96. If needles 318 a and 318 b have separate suture material connectedto their proximal end, there would be a different configuration.Furthermore, if the suture needles are configured to capture a needleretention element the needle capture element as illustrated anddescribed in connection with FIGS. 23-36 above, the suture material willtake still a different path. In any event, accurate positioning of thesuturing device 310 is enabled with the deployable foot 360.

Once the device 310 is sufficiently removed or completely removed, theneedles 318 a, 318 b and the attached suture material can be gathered inan appropriate fashion depending upon the number of individual lengthsof suture material. When desired, the needles can be separated from thesuture material. The suture material is gathered to gather to effectwound closure. A suture knot can be tied by hand. A loosely tied knotcan be advanced to the external surface of the vessel using a knotpusher. Alternatively, a knot box can be used to form a knot which isthen advanced to the external surface of the vessel. Examples ofsuitable knot boxes are illustrated and described in WO 01/19258, whichis incorporated herein by reference.

Alternatively, one or more knot replacement technologies such can beused to secure closure of the wound using the suture material.Consequently, the suture knot or suture securing devices can bepositioned across the proximal side of the wound to effect closure.

FIG. 21 is a perspective view of a suture securing device 102 for use inthe present invention. Suture securing device 102 is described andillustrated in US Patent Publication No. 2004/0102809 which isincorporated herein by reference. In use, device 102 can secure ends ofone, two, three or more lengths of suture material. Two lengths ofsuture material 104 a and 104 b are illustrated with device 102. Thelengths of suture material are threaded into the flexible elements 105 aand 105 b which are then locked or fixed together securing the suturematerial therein.

FIG. 22 is another embodiment of suture securing devices 106 a and 106 bfor use in the present invention. Devices 106 a and 106 b are describedin US Patent Publication No. 2003/0229377 which is incorporated hereinby reference in its entirety. Devices 106 a and 106 b cooperate byseparately clipping onto a selected length of suture material 104 a or104 b which have previously pulled taut to close wound or complete thesurgical procedure. The devices prevent the suture material fromregressing back through the sutured tissue.

FIG. 48 shows still other embodiment in which the receptacle 322 issized to receive one two or more needles 318 a, 318 b, 318 c, which canbe retained without any further modifications. Receptacle 322 includesone or more needle capture elements, for example, one or more plugs 123or pierceable material elements or projection(s) that can be pierced byneedles advanced into receptacle 322. In this embodiment, needle 318 ais captured within the receptacle reducing the risk of dislocationduring manipulation of the suturing device. Examples of suitable needlecapturing elements are illustrated and described in connection withFIGS. 23-36 above.

As shown in FIGS. 49 and 50, one or more needle engaging fittingsattached to suture material can be positioned within receptacle 322. Inthis embodiment, needles 318 a, 318 b, 318 c, . . . can each include arecessed surface 337 suitable for engaging with tabs 338 on fittings 344in the receptacle 322. Fittings 44 may be attached to suture material320, also at least partially contained within receptacle 322. Examplesof suitable fittings and needles are illustrated and described inconnection with FIGS. 1-22 above.

The present invention provides a variety of means, devices and methodsfor closing wounds in tissue and is particularly but not exclusivelysuitable for vascular tissue. It will be understood that the presentinvention contemplates modifications as would occur to those skilled inthe art without departing from the spirit of the present invention. Inaddition, the various structures, elements, and procedural steps orstages have been described with reference to specified embodiments anddevices. Each of the individual or a combination of the structures,elements, and procedural steps or stages are contemplated to becombinable with each of the other embodiments and devices describedherein and as such are contemplated to be within the scope of thepresent invention.

All publications, patents, and patent applications cited in thisspecification are herein incorporated by reference as if each individualpublication, patent, or patent application was specifically andindividually indicated to be incorporated by reference and set forth inits entirety herein. Further, any theory of operation, proof, or findingstated herein is meant to further enhance understanding of the presentinvention and is not intended to make the scope of the present inventiondependent upon such theory, proof, or finding.

1. A suturing device for suturing an opening in a vascular vessel, saiddevice comprising: a proximal member including an elongate body having aneedle channel therethrough sized to receive at least one needle andincluding a needle cartridge slidably mounted thereon configured tocontain a plurality of needles, the needle cartridge being biased toautomatically and successively align each of the plurality of needleswith the needle channel; a distal member configured to be insertedwithin a lumen of a vascular vessel, said distal member having areceptacle located therein; an intermediate member disposed between theproximal member and the distal member, said intermediate member defininga tissue receiving area and having a first opening providing apassageway to the channel and a second opening providing a passagewayinto the receptacle; a length of suture material comprising a needleengaging fitting positioned in the receptacle to engage a needleentering from the second opening.
 2. The device of claim 1 wherein theneedle engaging fitting comprises a ferrule having a needle engagingtab.
 3. The device of claim 2 wherein the ferrule comprises acylindrical housing having a plurality of tabs extending radiallyinward,
 4. The device of claim 1 comprising a needle having a recessedengaging surface configured to engage with the needle engaging tabs. 5.The device of claim 1 wherein the length of suture material comprises afirst needle engaging fitting on and first end and a second needleengaging fitting on a second end.
 6. The device of claim 1 comprisingtwo needle engaging fittings in the receptacle.
 7. The device of claim 1wherein the proximal member contains a single needle channel extendingtherethrough.
 8. The device of claim 1 wherein the connecting member iscurved or angled to define a tissue receiving recess configured toreceive a portion of vascular tissue adjacent the opening in thevascular vessel.
 9. The device of claim 1 comprising a needle pusherslidably mounted in alignment with the needle channel to advance aneedle along the needle channel in a direction toward the first openingin the connecting member.
 10. A method of suturing an opening in avascular vessel, said method comprising: inserting a vascular suturingdevice through the opening in the vascular vessel, said suturing devicecomprising a proximal member having a needle channel and a needletherein; a distal member configured to be inserted into the lumen of thevascular vessel, the distal member having a cavity therein and a lengthof suture material disposed in the cavity, the length of suture having afitting disposed on each end thereof, the fittings being positioned sideby side within the cavity; and a connecting member between the proximaland distal members, the connecting member being crooked to offset thechannel and the cavity from the opening in the vascular vessel andhaving a first opening into the needle channel and a second opening intothe cavity; advancing the needle through the needle channel, sufficientto pierce a portion of tissue adjacent the opening in the vessel andextend into the cavity of the distal member; capturing the suture withinthe cavity with the needle; and retracting the needle carrying a firstportion of the suture back through the tissue and the channel.
 11. Themethod of claim 10 comprising repositioning the suturing device withinthe lumen and advancing the same or a different needle through thechannel to the suture within the cavity.
 12. The method of claim 10comprising retracting the same or different needle carrying a secondlength of suture back through the tissue and the channel to leave a loopof suture within the cavity.
 13. The method of claim 10, the length ofsuture further comprising a second portion, the method furthercomprising securing the first and second portions of the suture togetherto promote hemostasis.
 14. The method of claim 13 wherein said securingcomprises tying the first and second portions of suture together. 15.The method of claim 13 wherein said securing comprises clamping thefirst and second portions of suture together with a suture clamp.
 16. Amethod of suturing vascular tissue adjacent an opening in a vascularvessel, said method comprising: inserting a suturing device through theopening in the vascular vessel, said suturing device comprising aproximal member having a needle channel and a needle therein, saidneedle carrying a length of suture material; a distal member configuredto be inserted into the lumen of the vascular vessel, the distal memberhaving a receptacle comprising a needle capture element and sized toreceive at least one needle therein; and an intermediate member disposedbetween the proximal member and the distal member, the intermediatemember defining a tissue receiving area and configured to provide alinear needle pathway between the channel and the receptacle; advancingthe needle distally along the needle channel to pierce the vasculartissue and draw a portion of the length of suture material through thevascular tissue; and engaging the needle with the needle capture elementin the receptacle.
 17. The method of claim 16 wherein engaging theneedle with said capture element comprises piercing the needle captureelement with at least a tip of the needle.
 18. The method of claim 16wherein the needle capture element comprises at least one projection andsaid engaging comprises contacting the needle with the at least oneprojection.
 19. The method of claim 18 wherein the said engagingcomprises inserting the needle between the at least one projection andan internal wall of the receptacle.
 20. The method of claim 16 whereinthe needle capture element comprises a plurality of projectionsextending into the receptacle and said engaging comprises inserting theneedle between two or more of the plurality of projections.
 21. Themethod of claim 16 comprising sequentially advancing two or more needlealong the needle channel and into the receptacle.
 22. The method ofclaim 16 comprising withdrawing the suturing device from the opening inthe vascular vessel with the needle retained within the receptacle. 23.The method of claim 22 comprising pulling suture material distallythrough vascular tissue adjacent the opening.
 24. The method of claim 23comprising pulling suture material proximally out the opening.
 25. Themethod of claim 24 comprising pulling two lengths of suture materialproximally out the opening.
 26. The method of claim 25 comprisingsecuring the two lengths of suture material together.
 27. The method ofclaim 26 wherein said securing comprises tying the two lengths of suturematerial together.
 28. The method of claim 26 wherein said securingcomprises using a suture securing device to secure the two lengths ofsuture material together.
 29. The method of claim 26 comprising using aknot pusher to secure the two lengths of suture material together.
 30. Amethod of suturing an opening in a vascular vessel, said methodcomprising: inserting a suturing device through the opening in thevascular vessel, said suturing device comprising a proximal memberhaving a needle channel therein; a distal member configured to beinserted into the lumen of the vascular vessel, the distal member havinga receptacle therein sized to receive at least one needle therein; anintermediate member disposed between the proximal and distal members,the intermediate member having a first opening providing a passageway tothe needle channel and a second opening providing a second passagewayinto the receptacle and wherein the intermediate member is crooked tooffset the needle channel and the receptacle from the opening in thevascular vessel; and a foot pivotally mounted on the intermediatemember; deploying the foot to contact vascular tissue adjacent theopening; and advancing a first needle through the needle channel topierce a portion of vascular tissue at a first suture site adjacent theopening in the vascular vessel and into the receptacle in the distalmember.
 31. The method of claim 30 comprising repositioning the suturingdevice to a second suturing site.
 32. The method of claim 30 wherein theneedle carries a length of suture material.
 33. The method of claim 32wherein the step of advancing said needle draws a length of suturematerial distally through a portion of vascular tissue adjacent theopening in the vascular vessel.
 34. The method of claim 31 comprisingretracting the foot to a first position prior to repositioning thesuturing device.
 35. The method of claim 30 wherein said deployingcomprises pivoting the foot from a first position adjacent the tissuereceiving area to a second position distal to the tissue receiving area.36. The method of claim 30 wherein said deploying comprises deployingthe foot after said inserting step.
 37. The method of claim 31comprising advancing a second needle carrying a second length of suturematerial through the needle channel to pierce tissue at the secondsuture site.
 38. The method of claim 32 comprising withdrawing thesuturing device from the vascular vessel.
 39. The method of claim 33wherein said withdrawing comprises drawing the first and second lengthsof suture material through the opening in a proximal direction.
 40. Themethod of claim 34 comprising securing the first length of suturematerial to the second length of suture material.
 41. The method ofclaim 36 wherein said securing comprises tying the first and secondportions of suture together.
 42. The method of claim 36 wherein saidsecuring comprises clamping the first and second portions of suturetogether with a suture securing device.
 43. The method of claim 34wherein the first length of suture material and the second length aretwo ends of a single length of suture material.